Abstract

Evidence suggests that many patients tolerate statin therapy after an adverse reaction. However, clinical outcomes of statin persistence after adverse reactions are unknown. We conducted a retrospective cohort analysis of the relationship between persistent statin therapy during 12 months after an adverse reaction, and cardiovascular (CV) events (myocardial infarctions and strokes) and death from any cause. We studied patients in primary care practices at two academic medical centers who reported an adverse reaction to a statin between 2000 and 2011 and were subsequently followed for at least 12 months. Adverse reactions to statins were identified using a combination of natural language processing of provider notes and EMR data. Among 28,279 study patients, 19,997 (70.7%) had persistent statin therapy after an adverse reaction. There were 10,203 (36.1%) patients at high CV risk (previous history of coronary artery disease (CAD), stroke or diabetes). Over a mean of 1,333 days of follow-up, 2,390 (8.45%) of patients suffered a CV event and 1,354 (4.8%) patients died. In univariate analysis, among patients at high CV risk 25.7% of patients who stopped statins reached composite primary outcome (CV event or death) vs. 19.6% of patients who had persistent statin therapy (Figure; p < 0.0001). In multivariable analysis adjusted for demographics, smoking status, Charlson Comorbidity Index, family history of stroke or CAD, blood pressure, body mass index, LDL cholesterol level, and renal function, persistent statin therapy was associated with a hazard ratio for primary outcome of 0.887 (95% CI 0.807 - 0.976; p=0.014). Persistent statin therapy was not associated with increased time to primary outcome in either univariate or multivariable analysis among patients with low baseline CV risk. Persistent statin therapy after a reported adverse reaction to a statin was associated with longer time to CV event or death in patients at high but not low CV risk.

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